Cassiopea gets U.S. FDA approval for acne treatment Winlevi (updated)

Cosmo NV

27/08/2020 07:21

(Adds details, background)
    ZURICH, Aug 27 (Reuters) - Swiss-listed drugmaker Cassiopea
 SKIN.S  said on Thursday it won approval for its first
medicine, an acne treatment, from the U.S. Food and Drug
Administration, setting the stage for a likely capital increase
to support its launch. 
    Winlevi, a twice-daily topical prescription medicine that
targets hormones called androgens, won approval for males and
females 12 years and older, Cassiopea said. Winlevi reduced acne
in trials. The most frequent local reaction was skin redness, or
erythema.
    Historically, acne has been treated by drugs called
retinoids that help unplug hair follicles, and antibiotics that
kill excess skin bacteria. 
    The drug is expected to be available in the United States in
early 2021 and Cassiopea plans to announce the price in the
fourth quarter. It did not give sales expectations.
    The company was spun off in 2015 by Cosmo Pharmaceuticals
 COPN.S  into a separate firm listed on the Swiss stock
exchange. Cosmo still owns just under half of Cassiopea.
    "We are excited to bring our first prescription drug to the
market and have built a detailed strategic and tactical launch
plan," said Cassiopea Chief Executive Diana Harbort, adding
Cosmo would support Cassiopea's plan to raise more capital for
the launch, but likely eventually monetize its investment. 
    The drug is also being studied against hair-loss causing
alopecia.
    Cassiopea shares are up about 10% this year.

 (Reporting by John Miller and Silke Koltrowitz; editing by
Thomas Seythal and Shailesh Kuber)
 ((silke.koltrowitz@thomsonreuters.com; +41 41 528 3638;))